Comparing two different anaesthesia techniques in prostate cancer patients for robotic surgery

Comparison Of Opioid-Free And Opioid Anaesthesia For Robot-Assisted Radical Prostatectomy: A Randomised Controlled Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/07/113848

Enrollment

Registered

2026-07-13

Start date

Unknown

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Dexmedetomidine-ketamine-lignocaine: Bispectral index guided non-opioids (Target Controlled Infusion of dexmedetomidine at effect site concentration 1.2ng/ml throughout robotic surgery

Eligibility

Inclusion criteria

Inclusion criteria: ASA I-III patients Weighing 51-80kg Undergoing elective robot-assisted radical prostatectomy

Exclusion criteria

Exclusion criteria: Patients who refuse to give consent Local anaesthetic allergy Glaucoma Raised intracranial pressure Deranged hepatic Function tests Deranged renal function tests Chronic opioid use Psychiatric illness Bradyarrhythmias

Design outcomes

Primary

Measure	Time frame
Quality of Recovery 15 ScoreTimepoint: Measured at baseline at 24 hours before surgery, and at 24 hours after end of surgery	—

Secondary

Measure	Time frame
Heart RateTimepoint: Measured at baseline, induction, intubation, pneumoperitoneum, docking, 30 min after docking, 60min after docking, 90min after docking, 120min after docking, on supination, at extubation, 1 hour post extubation, 2 hours post extubation, 4 hours post extubation, 6 hours post extubation, 12 hours post extubation, and 24 hours post extubation;Mean Arterial PressureTimepoint: Measured at baseline, induction, intubation, pneumoperitoneum, docking, 30 min after docking, 60min after docking, 90min after docking, 120min after docking, on supination, at extubation, 1 hour post extubation, 2 hours post extubation, 4 hours post extubation, 6 hours post extubation, 12 hours post extubation, and 24 hours post extubation;Bispectral IndexTimepoint: Measured at baseline, induction, intubation, pneumoperitoneum, docking, 30 min after docking, 60min after docking, 90min after docking, 120min after docking, and on supination;Respiratory RateTimepoint: Measured at extubation, 1 hour post extubation, 2 hours post extubation, 4 hours post extubation, 6 hours post extubation, 12 hours post extubation, and 24 hours post extubation;Numeric Rating Scale Score for PainTimepoint: Measured at extubation, 1 hour post extubation, 2 hours post extubation, 4 hours post extubation, 6 hours post extubation, 12 hours post extubation, and 24 hours post extubation;Total Fentanyl consumptionTimepoint: Measured at end of surgery and 24 hours after surgery;Total Morphine consumptionTimepoint: Measured at end of surgery and 24 hours after surgery;Opioid Related Adverse EventsTimepoint: Measured 24 hours after surgery;Time to first analgesicTimepoint: Measured 24 hours after surgery;Post Operative Nausea and VomitingTimepoint: Measured 24 hours after surgery;Time to ambulationTimepoint: Measured 24 hours after surgery;Time to oral intakeTimepoint: Measured 24 hours after surgery;Length of surgical intensive care unit stayTimepoint: Measured on shifting the patient to ward;Drug relate	—

Measure

Time frame

Heart RateTimepoint: Measured at baseline, induction, intubation, pneumoperitoneum, docking, 30 min after docking, 60min after docking, 90min after docking, 120min after docking, on supination, at extubation, 1 hour post extubation, 2 hours post extubation, 4 hours post extubation, 6 hours post extubation, 12 hours post extubation, and 24 hours post extubation;Mean Arterial PressureTimepoint: Measured at baseline, induction, intubation, pneumoperitoneum, docking, 30 min after docking, 60min after docking, 90min after docking, 120min after docking, on supination, at extubation, 1 hour post extubation, 2 hours post extubation, 4 hours post extubation, 6 hours post extubation, 12 hours post extubation, and 24 hours post extubation;Bispectral IndexTimepoint: Measured at baseline, induction, intubation, pneumoperitoneum, docking, 30 min after docking, 60min after docking, 90min after docking, 120min after docking, and on supination;Respiratory RateTimepoint: Measured at extubation, 1 hour post extubation, 2 hours post extubation, 4 hours post extubation, 6 hours post extubation, 12 hours post extubation, and 24 hours post extubation;Numeric Rating Scale Score for PainTimepoint: Measured at extubation, 1 hour post extubation, 2 hours post extubation, 4 hours post extubation, 6 hours post extubation, 12 hours post extubation, and 24 hours post extubation;Total Fentanyl consumptionTimepoint: Measured at end of surgery and 24 hours after surgery;Total Morphine consumptionTimepoint: Measured at end of surgery and 24 hours after surgery;Opioid Related Adverse EventsTimepoint: Measured 24 hours after surgery;Time to first analgesicTimepoint: Measured 24 hours after surgery;Post Operative Nausea and VomitingTimepoint: Measured 24 hours after surgery;Time to ambulationTimepoint: Measured 24 hours after surgery;Time to oral intakeTimepoint: Measured 24 hours after surgery;Length of surgical intensive care unit stayTimepoint: Measured on shifting the patient to ward;Drug relate

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Countries

India

Contacts

Public ContactDr Shagun Bhatia Shah

Rajiv Gandhi Cancer Institute and Research Centre

drshagun_2010@rediffmail.com9891769779

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026